Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - Any
Updated:8/12/2018
Start Date:April 7, 2014
End Date:July 6, 2017

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An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease

To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive
therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).

This is an interventional, multi-national, multi-site, open-label extension study in patients
with mild to moderate AD who completed the 24-week lead-in study 14861A (NCT01955161) or
14862A (NCT02006641).

Patients received 28-weeks of open-label treatment with idalopirdine 60 mg/day (option to
reduce to 30 mg/day) as adjunctive treatment to donepezil. Approximately 100 patients, who
had completed the initial 28-week period (OLEX), were included in a 24 week open-label
treatment period with memantine (OLEX-MEM) that evaluated the safety and tolerability of
concomitant memantine therapy in patients who were already on a stable treatment with
idalopirdine and donepezil and for whom memantine treatment was clinically indicated.

Inclusion Criteria:

- the patient has completed Visit 7 (Completion Visit) in the lead-in double-blind,
placebo controlled clinical studies 14861A/NCT01955161 or 14862A/NCT02006641

For patients in the OLEX-MEM:

- The patient has completed Visit 6 (Week 28) of the OLEX.

- The patient, according to the judgement of the investigator, requires initiation of
treatment with memantine as per local label/SmPC/treatment guidelines.

Exclusion Criteria:

- The patient has a moderate or severe ongoing adverse event from the lead-in study
considered a potential safety risk by the investigator.

- The patient has experienced seizures before Completion Visit in the lead-in study.

- The patient has evidence of clinically significant disease.

- The patient's donepezil treatment is likely to be interrupted or discontinued during
the study.

- The patient is receiving therapy with another acetylcholinesterase inhibitors (AChEI).

Other protocol-defined inclusion and exclusion criteria may apply.
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340 Lake Avenue
Lake Worth, Florida 33449
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Arlington, Virginia
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Atlanta, Georgia 30308
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Banfield,
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Birmingham, Alabama 35294
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344 Massachusetts Avenue
Boston, Massachusetts 02118
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Bradenton, Florida 34205
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Brooksville, Florida 34601
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Carlsbad, California
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Centerville, Ohio 45459
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Charlotte, North Carolina 28211
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Chicago, Illinois 60612
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Cincinnati, Ohio 45219
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Columbus, Ohio 43221
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306 South Ohio Avenue
Columbus, Ohio 43205
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Cordova, Tennessee
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Costa Mesa, California 92626
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Delray Beach, Florida 33445
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41 Flowood Drive
Flowood, Mississippi 39232
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Fort Worth, Texas 76107
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Freeport, Maine 04032
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Fullerton, California 92835
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Hallandale Beach, Florida 33009
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321 Mississippi Avenue
Hattiesburg, Mississippi 39401
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347 Hialeah Drive
Hialeah, Florida 33016
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12300 North Freeway
Houston, Texas 77060
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Imperial, California 92251
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Indianapolis, Indiana 46202
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Jenkintown, Pennsylvania
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Kailua, Hawaii
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Kalamazoo, Michigan 49048
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334 Lakeshore Drive
Lake Charles, Louisiana 70629
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352 West Ohio Place
Lakewood, Ohio 80226
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Little Rock, Arkansas 72205
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Long Beach, California
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Madison, Wisconsin 53705
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339 Manchester Boulevard
Manchester, New Jersey 08759
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Manhasset, New York 11030
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Miami, Florida 33186
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Miami, Florida 33137
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Milwaukee, Wisconsin 53226
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New York, New York 10032
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333 North Oklahoma Avenue
Oklahoma City, Oklahoma 73116
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345 Florida Avenue
Orange City, Florida 32763
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Orlando, Florida 32806
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Palm Beach Gardens, Florida 33418
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Phoenix, Arizona 85006
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Phoenix, Arizona 85013
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Pittsburgh, Pennsylvania 15260
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341 Penn Circle
Pittsburgh, Pennsylvania 15206
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Port Charlotte, Florida 33980
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Port Royal, South Carolina 29935
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Princeton, New Jersey
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Redlands, California 92374
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800 South Washington Avenue
Saint Paul, Minnesota 55401
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Santa Ana, California 92705
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Santa Rosa, California 95405
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Staten Island, New York 10312
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Sunrise, Florida 33019
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Toms River, New Jersey 08755
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